This study is for children and young people who haven’t reached their 18th birthday. We use the term ‘you’ in the summary but if you are a parent we are referring to your child.

More about this trial

When treating AML with chemotherapy there are 2 stages. The 1st stage is to get rid of the leukaemia cells in the bone marrow. This is called induction chemotherapy. The 2nd stage is to stop it coming back. This is called consolidation chemotherapy.

The combination of mitoxantrone and cytarabine is one of the standard treatments used for induction chemotherapy. This works but researchers are always looking for ways to improve treatment.

One way might be to increase the dose of chemotherapy. But this could increase the side effects caused by the chemotherapy.

Liposomal daunorubicin is a chemotherapy drug that is very similar to mitoxantrone. It was developed to be given in higher doses without increasing the side effects. But we don’t know if this is the case. So the researchers will compare:

mitoxantrone and cytarabine

liposomal daunorubicin and cytarabine

High dose cytarabine (HD Ara-C) is one of the standard treatments that doctors use for consolidation chemotherapy. It works but researchers are always looking for new ways to improve consolidation chemotherapy.

They think that the combination of fludarabine and cytarabine might work better as consolidation chemotherapy than HD Ara-C for people who have standard risk of their leukaemia coming back. So they want to compare

have already had treatment with chemotherapy or a biological therapy that could affect you taking part in this study for example previous treatment with an anthracycline chemotherapy drugs such as doxorubicin and idarubicin

have Down’s syndrome

are pregnant or breastfeeding

Trial design

This is an international phase 3 trial. In the UK the trial team need 300 people to join the MyeChild01 trial.

Induction chemotherapy
This is a randomised trial. People taking part are put into treatment groups by a computer. Neither you nor your doctor can choose which group you are in.

The 2 groups for induction chemotherapy are:

• mitoxantrone and cytarabine
• liposomal daunorubicin and cytarabine

Before stating treatment you have a central line put in. You have most of your treatment as a drip through the central line. You have the cytarabine as an injection into the fluid around the spinal cord (intrathecal injection). You have 1 or 2 treatments of induction chemotherapy.

Everyone has cytarabine twice a day for 10 days.

Those having mitoxantrone have it once a day for 4 days.

Those having liposomal daunorubicin have on the 1st, 3rd and 5th days of treatment.

After the 1st treatment the trial team will assess how well your leukaemia has responded and what the risk is of your leukaemia coming back.

Those who are at a high risk of their leukaemia coming back are considered for a stem cell transplant. Your doctor will talk to you about this.

Those who aren’t at a high risk of their leukaemia coming back have a 2nd treatment to complete their induction chemotherapy. It will be the same as the first.

After completing your induction chemotherapy the team will again assess the risk of your leukaemia coming back. Those who don’t have a high risk of their leukaemia coming back will have consolidation chemotherapy. Those who have a high risk of their leukaemia coming back will be considered for a stem cell transplant instead.

You might be asked to join another part of the MyeChild01 trial that is looking at consolidation chemotherapy or stem cell transplants. Your doctor will talk to you about this.

Consolidation chemotherapy
In the UK the trial team need 180 children and young people to join this part of the trial.

This part is also randomised. People taking part are put into treatment groups by a computer. Neither you nor your doctor can choose which group you are in.

The 2 groups are:

high dose cytarabine (HD Ara-C)

fludarabine and cytarabine (FLA)

You have most of your treatment as a drip into a central line. You have some of the cytarabine as an injection into the fluid around the spinal cord (intrathecal injection).

You have HD Ara-C twice a day on days 1, 3 and 5.

You have FLA once a day for 5 days.

Each 5 day period is called a course of treatment. You have 2 courses of treatment.

Tissue and blood samples
The trial team will ask for extra blood samples and bone marrow samples. These will be taken at the same time as the routine samples are taken.

They use some of the samples to look at different ways to measure how the leukaemia has responded to treatment. They hope this will help them identify people who are at a greater risk of their leukaemia coming back after treatment.

They also ask for a sample of cells from the inside of your cheek. They do this by wiping the inside of the cheek with a swab. This is used to look at the DNA in the cells. They also hope it will help them identify people who are at a greater risk of their leukaemia coming back after treatment. You don’t have to agree to this. You can still take part in the trial.

In the induction part of the trial the researchers also want to find out what happens to mitoxantrone and liposomal daunorubicin in the body. For this they take 8 or 9 extra blood samples over 5 to 7 days from your central line. You don’t have to agree to this. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part. These include:

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